Notable Milestones for the Company's
Programs
VANCOUVER, Nov. 26, 2019 /CNW/ - RepliCel Life Sciences Inc.
(OTCQB: REPCF) (TSXV: RP) (FRA: P6P2) ("RepliCel" or the
"Company"), a company developing next-generation technologies in
aesthetics and orthopedics, is pleased to provide an update to
shareholders.
Today RepliCel announced significant progress across all its
priority programs including:
- recent receipt of the final fully functional dermal injector
prototype (to be showcased in a dedicated announcement
shortly);
- near-completion of two-thirds of the regulatory reviews needed
in Japan for the tendon and skin
clinical programs;
- launch of a partnership program in Japan to identify strategic partners to
co-invest in development and commercialization of the tendon, skin
and device products in Japan;
- completion of the hair loss clinical study in Japan and demand for data delivery; and
- completion of YOFOTO's cell therapy manufacturing facility in
China, launch of tech transfer
training, and initiation of cell manufacturing validation
runs.
"We are pleased with the rapid progress made in China this year, very encouraged by the
positive regulatory reviews we have had to-date in Japan on our tendon/skin cell therapy
products, and excited by the potential we are seeing for a
high-value investment/partnership deal in Japan next year," stated RepliCel President
and CEO, R. Lee Buckler.
Earlier this year, RepliCel announced the development and launch
of a three-prong strategy focused on early commercialization and
near-term revenue-generation. Today RepliCel management and the
Board reported that the Company is tracking well against the
strategic plan the Board adopted for the Company's direction
priorities over the next 24-36 months encompassing 2019-2021.
At the core of this plan is:
- initial market launch of the RCI-02 device and consumables in
countries accepting CE mark regulatory designation for
commercialization in 2020.
- clinical development of the skin and tendon products in
China with YOFOTO;
- clinical development and commercialization of the NBDS product
line (RCT-01 for chronic tendinopathy and RCS-01 for aging and
sun-damaged skin) in Japan
including the necessary partnership structure to enable market
launch of both products potentially after a single, successful
clinical study in Japan.
The primary driver for this strategy is to drive the Company
toward revenue and the Board's objective of minimizing the need for
capital and dilution until the Company is
revenue-generating.
Of the secondary objectives announced earlier this year, the
Company has prioritized and posted progress on the following:
- Partnership discussions in Japan focused on our skin, tendon and dermal
injector products;
- Distributor discussions in Europe focused on the dermal injector and
consumables; and
- Clarifying Shiseido's plans for RCH-01 in Japan and Asia.
Below is a brief synopsis of recent progress, current status,
and near-term milestones in relation to each of RepliCel's
programs:
RCI-02 and consumables – We will have a fully functional
prototype of RepliCel's dermal injector and related consumables at
this year's annual general meeting to be held on November 27 in Vancouver. A team of Replicel representatives
including Buckler, Hoffmann, Schutte, Rueck, and King met at AMI's
facility in October with the engineers, project managers,
regulatory specialists involved in the final stages of the device's
development, production, testing, and regulatory approval. The
Company continues to anticipate that commercial-grade prototypes
will be available in Q4 to be immediately followed by the launch of
functional and clinical testing. Detailed planning is now underway
for CE mark submission and product launch next year.
RCT-01 – RepliCel's cell therapy for the treatment of chronic
tendon damage (Tendinopathy) has been the subject of a successful
phase 1 trial. RepliCel is now planning to execute next-phase
clinical trials of RCT-01 in Japan
where, subject to PMDA approvals, such a trial could launch next
year and be commercialized in Japan by late 2021/early 2022 following a
trial with successful outcomes. Following several pre-consultations
with the Japanese regulatory agency, the PMDA, we are now scheduled
to complete, by the end of 2019, two of the three formal
consultations necessary to launch clinical trials. We are now
preparing for the development of clinical trial design and
protocols to submit early next year. Co-development and partnership
discussions have now commenced in Japan around this product.
RCS-01 – RepliCel's cell therapy for the treatment of skin aging
and sun damage has been the subject of a successful phase 1 trial.
RepliCel is now planning to execute next-phase clinical trials of
RCS-01 in Japan as soon as the
RCI-02 device and consumables are available for use in Japan. Planning is now underway to launch a
clinical study of this product in Japan next year involving RepliCel's dermal
injector with the potential for it to be commercialized in
Japan by late 2021/early 2022
following a study with successful outcomes. Co-development and
partnership discussions have now commenced in Japan around this product.
RCH-01 – RepliCel's cell therapy for the treatment of Androgenic
Alopecia has been the subject of a successful phase 1 trial in
Europe and a clinical study now
complete in Japan. Shiseido is
expected to announce soon whether it will commercially launch the
product in Japan or conduct
further development and clinical testing. RepliCel will not plan
for a phase 2 clinical trial of this product until it has the
RCI-02 injector commercially available to use in such a trial and
it has clarity from Shiseido regarding its plans for the product in
Japan.
Partnership with Shiseido – The dispute regarding the status of
the agreement between Shiseido and RepliCel, for the license of
RCH-01 in Asia, remains unresolved
but is not the subject of any litigation or arbitration. RepliCel
maintains the Agreement remains intact and has recently demanded
that Shiseido share the data from the recently completed study of
RCH-01 in Japan. With the
completion of the Japanese RCH-01 study earlier this year, RepliCel
is now actively engaging Shiseido to deliver the study data and
reach a resolution to the dispute between the parties. RepliCel is
eager to end the ongoing dispute and work with Shiseido to
commercialize RCH-01.
Partnership with YOFOTO – YOFOTO recently completed the
manufacture and validation of its cell manufacturing facility and
is nearing completion of full technology transfer and training.
Next steps are to obtain the necessary regulatory approvals of its
manufacturing facility and proposed clinical trial protocols needed
to launch clinical trials of the tendon and skin products in
China.
Research and Development – The grant-funded research project
aimed at manufacturing optimization being conducted at the
University of Victoria continues
on-track. The first stage of the research being conducted at the
University of British Columbia has
successfully completed (details to be announced shortly) and plans
are being laid for the second stage. Further product and process
development, aimed at manufacturing improvements, will be
prioritized as funding permits.
Business Development – RepliCel's business development
activities are now exclusively focused on pursuing two types of
transactions in the coming months: (1) distribution and/or
licensing of the dermal injector and consumables, and (2)
licensing, investment, and/or the establishment of a joint venture
focused on Japan where the Company
is targeting partnerships for its tendon repair and skin
rejuvenation cell therapy programs as well as its dermal injector.
RepliCel anticipates one or more of these transactions will be
announced in the next 6-12 months.
Announcements anticipated before year-end include:
- audio-visual of the dermal injector demonstrating its functions
and utility;
- results from the first two formal consultations (of three
required) with the Japanese PMDA;
- first production run of the commercial-grade dermal injector
ordered; and
- further details regarding the dermal injector business
plan.
About RepliCel Life Sciences
RepliCel is a
regenerative medicine company focused on developing cell therapies
for aesthetic and orthopedic conditions affecting what the Company
believes is approximately one in three people in industrialized
nations, including aging/sun-damaged skin, pattern baldness, and
chronic tendon degeneration. These conditions, often
associated with aging, are caused by a deficit of healthy cells
required for normal tissue healing and function. These cell therapy
product candidates are based on RepliCel's innovative technology,
utilizing cell populations isolated from a patient's healthy hair
follicles.
The Company's product pipeline is comprised of RCT-01 for tendon
repair, RCS-01 for skin rejuvenation, and RCH-01 for hair
restoration. RCH-01 is exclusively licensed in Asia to Shiseido Company. RepliCel and
Shiseido are currently co-developing the product in Japan. RepliCel maintains the rights to RCH-01
for the rest of the world. RCT-01 and RCS-01 are exclusively
licensed in Greater China to
YOFOTO (China) Health Company.
RepliCel and YOFOTO are currently co-developing these products in
China. RepliCel maintains the
rights to these products outside of Greater China.
RepliCel has also developed a proprietary injection device,
RCI-02, and related consumables, which is expected to improve the
administration of its cell therapy products and certain other
injectables. YOFOTO has exclusively licensed the commercial rights
for the RCI-02 device and consumables in Greater China for dermatology applications and
is expected to first launch the product in Hong Kong upon it is CE marked. Please
visit www.replicel.com for additional information.
Neither TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in policies of the TSX Venture
Exchange) accepts responsibility for the adequacy or accuracy of
this release.
This press release contains forward-looking statements and
information that involve various risks and uncertainties regarding
future events, including, but not limited to, statements
regarding:
that the Company will launch its dermal injector (RCI-02) and
the consumables in countries accepting the CE mark regulatory
designation for commercialization by mid-2020; that the Company
will launch clinical development of its NBDS products in
China with YOFOTO in 2019/2020;
that the Company will obtain approval to launch the next-phase
clinical trials of its tendon product (RCI-01) and skin product
(RCS-01) in Japan in 2020 and
launch YOFOTO-sponsored trials in China; that the Company will continue its cell
marker research at UBC; that the Company will prepare for phase 2
studies of NBDS products in Europe; that the Company will enter into
partnership discussions (outside of greater China) for its RCI-01 device and cell therapy
products; that the Company will clarify Shiseido's plans for RCH-01
in Japan; that commercial grade
prototypes of its dermal injector and related consumables will be
available in Q4; that the Company will obtain CE mark approval next
year; that the Company will launch its next-phase clinical trials
of RCS-01 in Japan as soon as the
RCI-02 device and consumables are available in Japan; that the Company will receive clinical
data from Shiseido; that the Company will transition from being a
pre-revenue development company to generating commercial revenue;
and that the Company will be able to minimize dilution and maximize
shareholder value.
These statements are only predictions and involve known and
unknown risks which may cause actual results and the Company's
plans and objectives to differ materially from those expressed in
the forward-looking statements, including: risks related
YOFOTO spending the required amounts on RepliCel's
programs and related infrastructure over the next 5 years in
Greater China; risk related to
YOFOTO paying milestone payments and sales royalties;
risks that the Company's
products may not perform as, or have the benefits,
expected; risks that the Company's
products may not be accepted and
adopted by the public; the risk that the Company will not
obtain CE mark clearance for its injector device as
anticipated or at all; the risk that there will be delays
enrolling clinical trial participants or commencing any clinical or
research programs as anticipated or at all; the risk that the
Company will receive negative results from the Company's clinical
trials; the effects of government regulation on the Company's
business; risk that the Company may not obtain any further data
from Shiseido; risks associated with the Company obtaining all
necessary regulatory approvals for its various programs; risks
associated with the Company's ability to obtain and protect rights
to its intellectual property; risks and uncertainties associated
with the Company's ability to raise additional capital; and other
factors beyond the Company's control. Although the Company believes
that the expectations reflected in the forward-looking statements
are reasonable, it cannot guarantee future results, levels of
activity or performance. Further, any forward-looking statement
speaks only as of the date on which such statement is made and,
except as required by applicable law, the Company undertakes no
obligation to update any forward-looking statement to reflect
events or circumstances after the date on which such statement is
made or to reflect the occurrence of unanticipated events. New
factors emerge from time to time, and it is not possible for
management to predict all of such factors and to assess in advance
the impact of such factors on the Company's business or the extent
to which any factor, or combination of factors, may cause actual
results to differ materially from those contained in any
forward-looking statement. Readers should consult all of the
information set forth herein and should also refer to the risk
factor disclosure outlined in the Company's annual report on Form
20-F for the fiscal year ended December 31,
2018 and other periodic reports filed from time-to-time with
the Securities and Exchange Commission on Edgar at www.sec.gov and
with the British Columbia Securities Commission on SEDAR at
www.sedar.com.
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SOURCE RepliCel Life Sciences Inc.
